Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents in Denmark

Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents

A: Early predictors of hepatic injury after suicide attempt with acetaminophen:

To explore the following in a pediatric population with acetaminophen overdose due to suicide attempt: 1) the prevalence of episodes of pre- and in-hospital vomiting and the relationship between the total number of vomiting episodes and hepatic injury, 2) the relevance of the early initiation of N-acetylcysteine (NAC) treatment to hepatic injury, and 3) the presence/absence of illness prior to the suicide attempt and hepatic injury.

B: Characteristics, social behaviour, trends and risk factors:

1. To explore the relationship between children admitted to a paediatric department as a result of suicide attempts with acetaminophen and their parents and friends. 2. To determine the extent to which the children had attempted to speak to their parents or other adults about their problems before their suicide attempts. 3. To determine the prevalence of self-mutilation among children with suicidal behaviour. 4. To examine the reasons for these suicide attempts.

C: Establishment of the expression of cytochrome P450 in a pediatric including the age-adjusted activities.

Urine samples will be analyzed using an HPLC tandem mass spectrometric method, which we have already established in our lab.

There will be categorized three groups for comparison:

1. An age-appropriate background population (approximately 200 patients)
2. Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic injury (approximately 50 patients)
3. Other pediatric patients admitted to their local hospital because of acetaminophen poisoning (approximately 200 patients) A control urine sample will be analyzed three months after the suicide attempt.

Study Overview

• Status: Unknown
• Conditions: Hepatic Injury

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Rikke L. Hedeland, MD; Phone Number: 004548294356; Email: rikke.hedeland@regionh.dk

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Recruiting
    • Nordsjællands Hospital
    • Contact: Rikke L. Hedeland, MD
    • Principal Investigator: Rikke L. Hedeland, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric Department, children/adolescents who have tried to commit suicide with acetaminophen (8-18 years-old)

Description

Inclusion Criteria:

• 8-18 years-old, who tried to commit suicide with acetaminophen.
• Children are only included if they have answered all our standard questions.

Exclusion Criteria:

• Children with known liver disease prior to the suicide attempt.
• If a child have several suicide attempts during the inclusion-period, only the 1st will be included.
• Suicide attempts with other agents than acetaminophen.
• Children taking medication that enhance the induction of the cytochrome P450 system, increase the production of toxic metabolites, and aggravate the hepatic injury, such as ethanol, rifampin, isoniazid, barbiturates, and carbamazepine, will be excluded.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early predictors of hepatic injury	1) To identify early clinical and biochemical predictors of hepatoxicity in children and adolescents after the ingestion of a single acetaminophen overdose as a part of a suicide attempt e.g. pre-hospital vomiting, in-hospital vomiting, stomach pains, latency time before NAC treatment, illness prior to the suicide attempt. The initial and maximum levels of the following biochemical parameters are registered from the electronic biochemistry files of each patient: gluthathione (GLU), basic phosphatase (BP), INR, ALT, AST, and s-acetaminophen.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression of CYP 1A2 in a pediatric population	The expression of cytochrome P450 in a pediatric population including the age-adjusted activities. Urine samples will be analyzed using an HPLC tandem mass spectrometric method, which we have already established in our lab. There will be categorized three groups for comparison: An age-appropriate background population (approximately 200 patients) Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic injury (approximately 50 patients) Other pediatric patients admitted to their local hospital because of acetaminophen poisoning (approximately 200 patients) A control urine sample will be analyzed three months after the suicide attempt.	2 years
Characteristics, social behaviour, trends and risk factors	1)The relationship children with suicidal behaviour have with their parents and friends. 2)The prevalence of self-mutilation among children with suicidal behaviour. 3)The purposes and main reasons for suicide attempts among children/adolescents. 4) The extent to which these suicide attempts are planned. 5) The extent of acetaminophen intake.	2 years

Collaborators and Investigators

• Sponsor: Hillerod Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: November 5, 2013
• First Posted (Estimate): November 11, 2013

Study Record Updates

• Last Update Posted (Estimate): November 11, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Suicide; Acetaminophen; Attempts; Early Predictors of Hepatic Injury; Childhood Suicidal Behaviour
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: HIH-2011-17